FDA 483报告：印度Cipla（西普拉）.pdf

DEPARTMENT OF HEALTH AND HUMAN SERVICE S FOOD AND DRUG ADMINISTRATION D ISTRICT ADDRESS ANO PHONE NUMBER OATE(S) O F INSPECTION 12 4 20 Parklawn Drive, Room 2032 9/16/2019 - 9/27/2019* Rockville, MD 2085 7 FEJNUMBER 300 4 08 130 7 NAME AND TITLE O F INDIVIDUAL TO WHOM REPORT ISSU ED Mr . Ashwin Upasane, Sit e Head F IRM NAME STREET ADDRESS Cipla Limit ed L129 - 146 S - 103 - 10 5 S - 10 7 - 112 L147 - L147 1 C ITY . STATE. Z IP CODE. COUITTRY TYPE ESTABU SHM ENT INSPECTED Vasco Da Gama, Goa, 4 03 7 22 India Pharmaceut ical Manufact urer This document lists observations made by the FDA representative(s) during the inspection ofyom· facility. TI1ey are inspectional observations, and do not represent a final Agency determination regarding yom compliance. Ifyou have an objection regarding an observation, or have implemented, or plan to implement, co1Tective action in re sponse to an observation, you may discuss the objection or action v.rith the FDA representative{s) dtu-ing the inspection or submit this information to FDA at the address above. Ifyou have any questions, p lease contact FDA at the phone ntunber and address above. DURING AN INSPECTION OF YOUR FIRM WE OBSERVED: OBSERVATION 1 Equipment and utensils ar e n ot clean ed, m aintained an d sanitized at appropriate int